JP2023551914A - One-motion handle for steerable catheters - Google Patents

Abstract

A control handle for a steerable catheter allows precise manipulation of the distal catheter tip in a target organ or blood vessel using only one hand. The control handle can have a single articulation knob capable of both linear translation along the handle axis and rotation about the handle axis. These functions of the articulation knob actuate both expansion and retraction of the expandable member as well as bidirectional deflection of the distal catheter tip. The articulation knob functions consistently regardless of handle orientation, providing ergonomic movement that allows the user to comfortably maintain attention to the procedure monitoring equipment. These improvements can lead to safer and faster procedure times for diagnostics and procedures such as cardiac ablation.

Description

FIELD OF THE INVENTION The present invention relates generally to control handles for intravascular catheter systems, and more specifically, the present disclosure relates to improved handles for steerable catheters that can be operated with one hand.

Abnormal or irregular electrical signals in areas of heart tissue can disrupt normal heart rhythm. Cardiac arrhythmias are the result of irregular heartbeat cycles in which these electrical signals are not properly regulated. Such conditions, including paroxysmal atrial fibrillation (PAF), often occur either through disruption of the source of the signal or through severing the conduction path of the signal through the pulmonary veins. be treated by.

Many procedures require the use of multifunctional catheters with tip mechanisms that can be steered or expanded and retracted. Many such procedures, such as diagnostic mapping and ablation, require high levels of precision. Ablation techniques are commonly used to stop or modify the propagation of unwanted electrical signals from one part of the heart to another. This process involves applying energy from electrodes to tissue, disrupting unwanted electrical pathways through the formation of non-conducting lesions. The applied energy can be radiofrequency (RF), low temperature, irreversible electroporation (IRE), or other similar techniques. Successful patient outcomes often depend on precisely targeted isolation of the pulmonary veins in the subject's left atrium to eliminate symptoms. The deployment of delivery capability-specific catheters and precision ablation assemblies into expanded configurations after delivery creates a continuing challenge to improve control elements for these systems.

A typical catheter system usually involves an elongated flexible catheter shaft extending from a proximal luer or control handle that includes an actuation mechanism. Some of these catheters are capable of delivering a steerable tip into the heart or other tissues of the body for purposes of ablation, diagnosis, and other functions to aid in therapy. . The use of a radially expanding device with an RF electrode to form a circumferential lesion at or near the ostium of a pulmonary vein to treat atrial arrhythmia is disclosed in U.S. Patent No. 6, both to Lesh. , 012,457 and 6,024,740. In addition, U.S. Patent Publication No. 2016/0175041 to Govari et al., assigned to the present applicant and incorporated herein by reference, teaches that atraumatic contact with a venous ostium is a consistent circumference surrounding the vein. A catheter with an expandable balloon having an electrode assembly disposed around its exterior is utilized so that a sexual lesion can be generated.

However, intravascular procedures using steerable catheters are still hampered by the difficulty experienced by users when attempting to maneuver the catheter tip into the correct tissue location. Although existing catheters have maneuverability and deflection control, they often have limited maneuverability. This is particularly true for procedures where particularly fine movement control is required. Additionally, existing designs are often capable of deflection along a single plane, requiring the user to rotate the entire device to access three-dimensional locations that are not parallel to the deflection plane. means. This combination of factors can make many procedures, such as aligning ablation electrodes, difficult and time-consuming tasks. Uneven or incomplete ablation can lead to debris embolization or even treatment failure, and long fluoroscopy and procedure times can also lead to complications.

Additionally, attention to detail and knowledge of exactly how specific equipment responds to inputs is critical to a successful surgery. The control member or handle is important for maneuverability and steering of the catheter shaft, both for passage through the aortic arch and for positioning for the ablation process. There is often a lever or rotating member on the handle to steer the tip that causes the deflection. A slidable button or toggle mechanism may also be used. Handle precision and comfort are important because if the catheter is deflected, deflected, or rotated in the wrong direction, serious injury to the patient can occur. Similarly, physicians who must repeatedly look away from their diagnostic tools to see where their hands are positioned and which parts of the handles need to be actuated can spend significant amounts of time on surgical procedures. May be added.

Examples of several different handle mechanisms for control of catheters and catheter tips designed for electrophysiological mapping and/or ablation can be found in the art. US Pat. No. 5,944,690 to Falwell et al. discloses a steerable catheter control design that utilizes a slider mechanism to manipulate control wires. However, depending on the position of the slider mechanism, the design may require awkward twisting of the hand to allow the thumb or another finger to further adjust the slider. A single slider may also lack the precision necessary for fine manipulation and adjustment of the catheter.

For ablation procedures, the geometry and size of pulmonary veins often require a much larger ablation diameter than a typical delivery catheter or sheath. As a result, many circumferential ablation devices have both a flexible small profile for delivery within an outer catheter and a deployed and expanded configuration at the target site for precise ablation and diagnosis. is required. Activating this extension often requires additional functionality, fittings, or devices connected to or supplied through the handle, complicating setup and requiring additional functionality to operate. Needs a hand. Similar capabilities are also required to retract the device for retraction into the sheath or outer catheter upon completion of the procedure.

US Patent Publication No. 2019/0083751 to Busseler discloses a plunger-type or slider-type actuation mechanism for a medical device having a deflectable distal region. The device utilizes control wire pinching as a means of securing or self-locking the mechanism to eliminate the need for a secondary locking mechanism and reduce operator fatigue. However, plunger-type mechanisms also have limited fine adjustment capabilities. Additionally, these designs lack the ability for further expansion or deployment capabilities beyond tip manipulation.

A control handle for a steerable catheter disclosed in US Patent Publication No. 2016/0331932 to Davies et al. utilizes a control wire articulated by one or more handle-mounted rotary knobs. Tensioning the wire causes distal deflection of the catheter tip. However, this design can have multiple knobs on both the proximal and distal ends of the handle, and may require multiple hands to operate in certain situations, while the tip It also lacks the ability to operate any further functions other than control.

Different physicians may also have different preferences in how they prefer to hold the handle during a procedure. Conventional handles or systems can have a variety of control surfaces that can be located proximally or distally on the handle, which the clinician can control based on personal preference and/or particular hand preference. Requires a significant match. Therefore, these designs may not provide the necessary comfort for the user while operating and adjusting the handle.

Accordingly, an improved device, system, and control handle for a control handle that allows precise steering control of a deflectable tip while also actuating additional tip functions such as expansion and contraction of an expandable member. A method is needed. It is also very favorable that the articulation of these functions can be performed with one hand, so that the ergonomics of the handle does not cause fatigue to the operator.

It is an object of the present invention to provide a system, device and method that meet the above-mentioned needs. In general, there is a particular need for precise control and actuation of catheters having mechanisms and devices capable of extension and retraction and multi-directional deflection. Devices capable of consistent performance during a procedure are often configured in a collapsed delivery state and configured to deliver energy around the entire circumference of the entry site or to detect cardiac signals for diagnosis over a significant area. It must be possible to launch between expanded and expanded states sized to . Although often mentioned in connection with cardiac ablation or diagnostic procedures as examples, many other potential applications for such control handles involve remote actuation of an expandable member at a target site. It can be envisaged that any endovascular procedure that involves

A control handle for a steerable tip catheter can have an outer housing having a substantially tubular shape, a proximal end, and a distal end. An articulation knob for controlling the function of the catheter tip is positioned proximate the distal end and is rotatable about the longitudinal axis of the outer housing of the handle, such that it is linearly displaceable therealong. may be configured. The handle housing and knob can be sized such that all functions and movements of the knob can be performed comfortably with one hand, thus allowing the user to refer to the respective positions of the handle components. There is no need to look down or use another hand for manipulation during the procedure. Movably disposed within the outer housing can be a drive housing longitudinally coupled to the articulation knob. Movement of the drive housing can actuate the control member to initiate the function of the handle. The control member can include components such as control wires, sliding levers, or toggles.

In one embodiment, the catheter is steerable for use in ablation of tissue in or around the heart to form enhanced lesions as a treatment to disrupt unwanted cardiac electrical signals. It can have an electrode at its tip. For example, one or more independently controlled electrodes may be equally spaced on the surface and around the circumference of the inflatable balloon. In another example, the electrode can be located on the outside of the structure, which can be configured to expand when deployed from the delivery catheter at the target site. In this configuration, the catheter can have one or more Luer fittings configured to receive fluid injection for irrigation of the ablation site and/or cooling of the tip electrode.

In another example, the catheter may be triggered to expand in radial size or change shape, for example, to perform electrophysiological mapping and imaging of healthy and unhealthy tissue of the heart. It can have a tip. Such systems are also often capable of determining the velocity and direction of cardiac signals.

The articulation knob may be configured to provide first, second, and third linear displacements to the drive housing parallel to a longitudinal axis of the handle outer housing. In some cases, a first linear displacement of the drive housing activates a function of a first control member of the steerable tip and a second linear displacement activates a function of a second control member. A first linear displacement can occur when the knob is rotated clockwise about the longitudinal axis, and a second linear displacement can occur when the knob is rotated counterclockwise. The opposite of displacement can occur. These opposite displacements tension the control wires or cables coupled to the distal end of the catheter, causing the steerable tip to move in opposite directions to direct fine movements of the tip at the target site in the vasculature. Deflect angularly at .

A third linear displacement of the drive housing can occur when the articulation knob is translated a distal or proximal distance parallel to the longitudinal axis. Linear translation of the knob can be achieved independent of any rotation imparted to the knob. This movement increases the radial size of the expandable member at the distal tip of a steerable catheter, such as an ablation balloon system for treating arrhythmia, or a diagnostic tool configured to record cardiac signals from tissue. may be configured to vary. This radial size may be actuated and controlled by an advancement mechanism coupled proximally to the drive housing and distally to the expandable element. Distal translation of the articulation knob can push the advancement mechanism distally to axially extend or elongate the expandable element, reducing its corresponding radial size. A similar proximal linear translation of the knob can pull the advancement mechanism to axially shorten and expand the expandable element. To accomplish this actuation, the advancement mechanism can be constructed from a strong but flexible organic material, such as polyimide tubing.

The advancement mechanism can be an elongate tubular member and can have a hollow interior lumen. The lumen allows the advancement mechanism to be used for distal delivery of various auxiliary devices or treatments such as guidewires, microcatheter-based systems, mapping catheters, or contrast agents.

In a further example, the situation is where linear translation of the articulation knob along the longitudinal axis actuates the steerable tip to angularly deflect in opposite directions to direct fine motor control. The rotation of the articulation knob may be reversed and configured to control the radial size of the expandable element. Thus, functionality can be tailored to the ergonomic preferences of a particular user or the ease of performing a particular procedure.

The articulation knob of the control handle includes a hub, a proximal end, and a distal opening through which the catheter body and any associated interior, such as the advancement mechanism and control member, can pass to the exterior of the handle. be able to. The inner diameter of the knob hub can have at least one keyway machined or formed into the surface. Rotatably coupled to the articulation knob can be a barrel nut. The barrel nut can include one or more keys, a thrust collar, and an internal drive spline. A keyway in the knob hub can transmit torque to a key in a barrel nut that can be longitudinally rotationally coupled to the drive housing via the thrust collar and drive spline threads, respectively. The thrust collar can act as a mechanical stop for transmitting linear displacement to the drive housing.

The drive housing can have a split piston carriage that can include a right flexure rack and a left flexure rack movable relative to each other in a controllable manner within the outer housing. The distal portions of the right and left flexure racks may form a drive bolt having external threads configured to engage female drive spline threads of the barrel nut. The pinion gear engages the internal axial teeth of the right and left flexural racks and can rotate when there is relative movement between the racks. Clockwise rotation of the articulation knob may result in translation of the right flexural rack relative to the left flexural rack in a first direction along a linear path, tensioning the wire or other control element. Similarly, counterclockwise rotation of the knob can result in a second relative linear translation in a second direction opposite the first direction, tensioning the same or a different wire or control element.

Features such as relief notches or detents, knobs, drive bolts, etc. at various axial or clocking positions to act as engagement points to selectively maintain a particular tip deflection or radial size of the expansion element. , the drive housing, or the barrel nut. Alternatively, the element may be used to create a friction lock to maintain the position of the articulation knob relative to the handle to prevent unintentional movement during the procedure. These elements can be rubber seals, grommets, or other common components known in the art. Accordingly, the knob assembly may be capable of maintaining a particular angular and longitudinal position to correspond to a desired discrete deflection or radial size of the expandable element.

In another embodiment, the handle portion controlling the steerable catheter includes a deflection thumb knob that allows for bidirectional deflection, a balloon disposed about or connected to the distal portion of the catheter body, and a balloon disposed about or connected to the distal portion of the catheter body. It can include an advancement mechanism and a Luer fitting for balloon inflation and irrigation. An additional Luer fitting may be located near the distal end of the handle portion having a lumen extending through the handle, the catheter body, the advancement mechanism, and the balloon and in fluid communication with the distal-most tip of the catheter. . This Luer fitting and lumen can serve as an entry port for a guidewire or other small device, as well as provide irrigation and contrast injection distal to the balloon of the catheter.

Also provided is an exemplary method for controlling a steerable catheter with a control handle during an intracardiac procedure. The method may include some of the following steps, presented in no particular order. Examples can include introducing a steerable catheter into the vasculature, the catheter comprising a catheter shaft having a proximal region, a deflectable distal region, and a control handle. The control handle can have an outer shell, a distal knob assembly capable of linear translation along and rotation about a longitudinal axis of the handle, and a drive assembly movably disposed on the outer shell. The drive assembly can have an inner housing, a distal drive bolt, and a split piston carriage threadably engaged with the distal knob assembly.

The distal knob assembly may be linearly displaced along the longitudinal axis to actuate expansion or retraction of the expandable element on the distal end of the steerable catheter. In embodiments, linearly displacing the knob proximally with respect to the outer shell can increase the radial size of the expandable element, while a corresponding distal displacement increases the radial size of the expandable element. The size can be reduced. Rotation of the distal knob assembly about the longitudinal axis can be caused by angular deflection of the steerable tip by actuating a control member that can be coupled to the drive assembly. A clockwise rotation of the knob can deflect the tip in one direction, while a corresponding counterclockwise rotation can deflect the tip in the opposite direction along the same plane.

Method steps involving rotation and translation of the distal knob assembly can occur independently of each other. For example, the knob may be positioned such that the expandable element exhibits a small radial size to facilitate delivery to the site targeted for ablation. Upon reaching the site immediately proximal to the target, the expandable element can be expanded to the desired larger radial size based on the size of the patient's entrance through proximal translation of the knob. Thus, an expandable element such as an ablation balloon with independently controlled electrodes around its circumference can be prepared for treatment without tip deflection or tissue contact. The desired radial size of the expandable element may then be maintained while final steering adjustments are made by rotating the knob to deflect the distal tip into position.

Furthermore, while the handle may be held with one hand, deflection and rotation of the knob is performed by the thumb and fingers of the same hand. By not requiring a second hand, the user does not have to look away from the procedure to refer to the position or orientation of the handle, and can remain focused on the associated monitoring equipment of the procedure.

The method can further include the step of including an internal physical stop or other similar method to limit translational movement, rotational movement, or both translational and rotational movement of the knob assembly of the handle. Limits may be placed so that the physician is aware of the absolute movement capabilities and performance of the catheter before and during the procedure. For example, knowing these limitations may be advantageous in situations where tip deflection is out of plane at the physician's own viewing angle. The intermediate axial position of the knob may also be configured to accommodate discrete radial sizes of the expandable element so that the expandable element can conform to different anatomical shapes.

Another method for manipulating the distal tip of a catheter with only one hand can include positioning the catheter within a blood vessel. The catheter can have an elongate tubular member having a steerable distal tip and a control handle proximal to the elongate tubular member. The control handle can have an outer housing and a control knob configured for translational and rotational movement relative to the outer housing. Inside the outer housing there can be a control assembly coupled to the control knob such that linear displacement and angular rotation of the control knob actuates control functions of the distal tip of the catheter.

Actuation can occur through multiple methods, such as tensioning a control wire and/or using a post to apply an axial thrust load to a portion of the distal tip of the elongated tubular member. Once the tip is positioned proximal to the target location, the control knob may be linearly displaced along the longitudinal axis of the housing to expand and deploy the expandable element at the distal tip. can. Grooves or recesses may be configured within the handle to allow the control knob to maintain certain intermediate discrete angular or axial positions. The element can take many forms, such as a balloon having multiple independently controlled electrodes configured around its circumference for ablation of pulmonary veins. To further orient the tip, the control knob is rotated clockwise to deflect the distal tip in a first direction, or rotated clockwise to deflect the tip in a second direction opposite the first direction. It can be rotated counterclockwise.

A plurality of independently controlled electrodes may be equally spaced around the circumference of the expandable element. The expandable element can be maneuvered into circumferential line contact with the wall of the pulmonary vein, and the tissue surrounding the line contact is ablated by directing energy from an energy source, such as an RF generator, through a conductor to an electrode. can be done. Further steps may involve using the control handle to direct the tip to isolate subsequent ablation locations during the procedure. Once the ablation is complete, the control knob of the handle can be linearly displaced distally to collapse the expandable element to a smaller radial size, such that the expandable element is ready for extraction from the patient. It can then be reloaded into the sheath or outer catheter.

In addition to those listed herein, additional steps may be included as will be recognized and understood by those skilled in the art. The example methods may be performed by the example control handles disclosed herein, variations thereof, or alternatives thereof, as will be understood by those skilled in the art.

Other aspects and features of the disclosure will become apparent from the following detailed description when considered in conjunction with the accompanying figures.

The above and further aspects of the invention will be further discussed with reference to the following description in conjunction with the accompanying drawings, in which like numerals indicate similar structural elements and features in the various figures. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. The figures depict, by way of example only and not by way of limitation, one or more implementations of a device of the invention.
FIG. 3 is a system level diagram of a control handle that is operable with one hand and that is capable of activating multiple functions of a distal tip of a steerable catheter, in accordance with an aspect of the present invention. FIG. 3 is an isometric view of a control handle according to an aspect of the invention. FIG. 3 is a top view of the control handle of FIG. 2 in accordance with aspects of the present invention. 3 is a side view of the control handle of FIG. 2, in accordance with an aspect of the present invention. FIG. 2 is an illustration of a control handle with the top of the outer housing removed, according to an aspect of the invention; FIG. 2 is an example of an expandable ablation balloon capable of being both expanded and deflected by a control handle, in accordance with aspects of the present invention. FIG. 3 is a side cross-sectional view of the control handle showing the handle interfacing with the drive housing, in accordance with an aspect of the present invention. FIG. 3 is a cross-sectional view from the top of the control handle showing the handle interfacing with the drive housing, in accordance with an aspect of the present invention. FIG. 9 is an enlarged cross-sectional view of the cross-sectional view from FIG. 8 illustrating the coupling of the barrel nut and piston carriage in accordance with an aspect of the present invention. FIG. 6 illustrates a drive housing and piston carriage of a control handle without an outer housing, articulation knob, or barrel nut, according to an aspect of the invention. 11 is a cross-sectional view from FIG. 10 just distal of the pinion, according to an embodiment of the invention; FIG. 3 illustrates right and left flexural racks, respectively, in accordance with aspects of the present invention. 3 illustrates right and left flexural racks, respectively, in accordance with aspects of the present invention. FIG. 6 illustrates a lower half of a control handle drive housing in accordance with an aspect of the present invention. FIG. 4 is an isometric view of a handle articulation knob, in accordance with an aspect of the invention. FIG. 3 is a cross-sectional view of an articulation knob according to an aspect of the invention. FIG. 3 is a perspective view of an articulation knob from the proximal end, according to an aspect of the invention. FIG. 3 is an isometric view of a barrel nut of a handle, according to an aspect of the invention. FIG. 2 is a cross-sectional view of a barrel nut according to an embodiment of the invention. 2 illustrates an example of an expandable ablation balloon as actuated by an advancement mechanism in its delivery and expansion deployment configurations, respectively, in accordance with aspects of the present invention. 2 illustrates an example of an expandable ablation balloon as actuated by an advancement mechanism in its delivery and expansion deployment configurations, respectively, in accordance with aspects of the present invention. 2 illustrates a shaft of a steerable catheter according to an embodiment of the invention. FIG. 19 is an enlarged cross-sectional view of the shaft of FIG. 18 showing some of the internal control elements, in accordance with aspects of the present invention. FIG. 3 is a series of cross-sectional views illustrating how different displacements and rotations of the articulation knob operate the function of the distal tip of the steerable catheter, in accordance with aspects of the present invention. FIG. 3 is a series of cross-sectional views illustrating how different displacements and rotations of the articulation knob operate the function of the distal tip of the steerable catheter, in accordance with aspects of the present invention. FIG. 3 is a series of cross-sectional views illustrating how different displacements and rotations of the articulation knob operate the function of the distal tip of the steerable catheter, in accordance with aspects of the present invention. FIG. 3 is a series of cross-sectional views illustrating how different displacements and rotations of the articulation knob operate the function of the distal tip of the steerable catheter, in accordance with aspects of the present invention. FIG. 3 is a series of cross-sectional views illustrating how different displacements and rotations of the articulation knob operate the function of the distal tip of the steerable catheter, in accordance with aspects of the present invention. FIG. 3 is a series of cross-sectional views illustrating how different displacements and rotations of the articulation knob operate the function of the distal tip of the steerable catheter, in accordance with aspects of the present invention. FIG. 3 illustrates an example of an expandable ablation balloon with independently controlled electrodes around its circumference for performing ablation of a pulmonary vein, in accordance with aspects of the present invention. FIG. 2 is a flowchart outlining a method for using a control handle to operate a distal tip of a steerable catheter, according to an aspect of the invention. 2 is a flowchart outlining a method for using a control handle to operate a distal tip of a steerable catheter, according to an aspect of the invention.

Specific embodiments of the invention will now be described in detail with reference to the drawings, in which like reference numbers indicate functionally similar or identical elements. The drawing shows a control handle for a steerable catheter that can be operated with one hand to improve ergonomics for the operator while controlling the steerable and expandable features of the catheter's distal tip. exemplify. The articulation knob on the control handle functions consistently regardless of handle orientation, providing ergonomic movement that allows the user to comfortably maintain their attention on the monitoring equipment while performing the procedure. do. These improvements can lead to safer and faster treatment times.

Although often referred to herein in the context of ablation procedures, the disclosed control handles may be applicable to catheters with activated tip features for a variety of procedures such as mapping or diagnostics. can be understood. Accessing the various vessels within the vasculature, whether coronary, pulmonary, or cerebrovascular, involves well-known procedural steps and the use of many conventional commercially available accessory products. . These products, such as angiographic materials, rotating hemostasis valves, and guidewires, are widely used in laboratories and medical procedures. When these products are used in conjunction with the systems and methods of the present invention in the following description, their functionality and exact configuration will not be described in detail. Although the description is often related to cardiac ablation therapy, the systems and methods can be used for other procedures and in other body passageways as well.

Steerable catheters or sheaths may be utilized to gain access to target locations within the body. Such devices can have control mechanisms for providing access to areas of the body through the vasculature using minimally invasive procedures. In some of these procedures, the tip of the catheter or sheath may be required to provide access by deflecting in more than one direction. For other procedures, the tip may require expandable functionality at the target site.

Turning to the drawings, FIG. 1 illustrates a steerable control system or handle 100 for operating a medical device while performing an endovascular procedure. Medical devices can include, by way of example, catheters, sheaths, introducers, or similar devices. Such devices are often used for cardiac ablation, mapping, diagnostics, thrombectomy, and other procedures. Handle 100 may be coupled to catheter shaft or sheath 27 to allow a user to use the handle to orient and maneuver the shaft. Handle 100 can include an articulation knob 210 coupled to outer shell or housing 110. Knob 210 may be independently rotated and linearly translated relative to handle outer shell 110. The handle 100 may further include a connection for a catheter cable 30 coupled to a diagnostic hub of a function generator or navigation system for transmitting and/or receiving data during a procedure.

In some cases, handle 100 can have one or more Luer fittings 40 for injecting fluid through outer housing 110 using a syringe, pump, or other means. The fluid can be a contrast agent, saline, or other solution and can be used for any of a number of purposes, depending on the procedure. These may include angiography, irrigation, cooling, or inflation of a balloon or other expandable member.

In use, rotation of the articulation knob 210 in a first clockwise rotational direction relative to the outer housing 110 of the handle 100 allows the user to deflect and steer the deflectable segment 26 of the catheter shaft 27. I can do it. Similarly, rotation of the knob in a second counterclockwise direction of rotation may allow deflection and steering in the opposite direction. In other embodiments, the bidirectionally steerable catheter is configured to deflect in two distinct deflection directions that are out of plane with each other.

Linear deflection of the articulation knob 210 relative to the outer housing 110 of the handle 100 can control another function of the steerable distal tip 50 of the catheter. For example, the degree of axial displacement proximally or distally can be expanded from a smaller delivery configuration to an expanded deployed state that may be necessary to perform a particular procedure. The radial size of elements can be varied. When the catheter tip 50 needs to be repositioned, or at the end of a procedure, axial displacement in the direction opposite to that used to expand the element may cause the element to be repositioned to a smaller size or larger for maneuverability. It can be applied to restore shape.

2-4 show views of different orientations of the control handle design. Referring to FIG. 2, the outer housing 110 of the control handle 100 can be generally tubular in shape. Catheter shaft 27 may extend through distal end 113 of handle 100. Articulation knob 210 is mounted distally on outer housing 110 so that when the handle is held in the palm of the hand, all functions of the knob can be operated using the thumb and/or index finger of the same hand. can be placed in Catheter shaft 27 can extend inside outer housing 110 such that the shaft is not impinged by the knob and the knob is free to translate and rotate along its full range of motion. The proximal end 112 of the handle 100 may have additional fittings or passageways for other auxiliary equipment needed for the desired procedure or for further fluid injection for irrigation and/or contrast media. I can do it.

The elements visualized in the drawings may be described as tubular structures and are generally illustrated as substantially right cylindrical structures. However, as used herein, the terms "tubular" and "tube" are to be interpreted broadly. They are not meant to be limited to structures that are right cylindrical, ie, strictly circular in cross-section or of uniform cross-section over their length.

The outer housing 110 of the handle 100 can be split in half for manufacturing and assembly, as seen in FIG. The housing has an upper shell 120 and a lower shell 130, which may or may not be equal in radial size and may be secured together within the housing by fasteners, snap-fits, adhesives, or other suitable means. be able to. The outer housing 110 can house all actuation of the handle's control functions so that there are no sharp edges or buttons to snag and the articulation knob 210 is the only movable control surface.

Referring to FIG. 5, outer housing 110 provides a hollow shell for surrounding drive housing 410 and allows linear translation of the drive housing therein along longitudinal axis 111. This view depicts the assembly with the articulation knob 210 and the upper half of the outer housing removed, with the drive housing 410 disposed within the outer lower shell 130 and sharing the longitudinal axis 111. The drive housing may be coupled axially to the articulation knob such that linear translation of the drive housing within the outer housing is driven directly by linear translation applied to the articulation knob by a user. Catheter shaft 27 may be coupled proximally within a portion of drive housing 410 so as to be controlled by rotational and translational movement of handle 100. The handle can terminate in a proximal end 112 that can be used to interface with a cabled connector or additional Luer fitting for irrigation or contrast injection. Alternatively, proximal end 112 can have a secondary entry point for a guidewire or similar small diameter device.

The distal tip 50 of the catheter can take many forms depending on the needs of the procedure being performed. The handle 100 can be useful in any distal tip design that can expand and collapse or change its shape configuration. In one example, the tip can have an expandable cage or basket-like structure or can be configured to monitor and map cardiac signals for diagnostic purposes. In another example, the catheter may be adapted to deliver energy for cardiac ablation. The distal tip 50 of the catheter in this example can be an expandable balloon ablation system, as seen in FIG. 6 and described in the aforementioned US Patent Publication No. 2016/0175041. In this example, a conformable balloon 610 may be used to isolate a pulmonary vein within the subject's left atrium. Balloon 610 can expand into a generally spherical or oval shape about longitudinal axis 51 of tip 50. The distal end 614 of the balloon can be atraumatically tapered into an extension collar 630 proximate the distal end of the balloon.

Lumen 622 can extend through catheter shaft 27, balloon 610, and extension collar 630. Lumen 622 can allow access distal to the ablation site and can function as a delivery channel for distal irrigation, contrast injection, and/or guidewires and other small diameter devices. . For example, a lumen diameter of 0.050 inch can accommodate a guidewire up to 0.035 inch while maintaining irrigation through lumen 622 to prevent blood clotting. .

High torque shaft 27 can enable steerable catheter tip 50 to have the deliverability and level fidelity needed for precise treatment. The shaft can transition distally into a steerable and deflectable tip segment 26 that is controlled by handle 100. Inside the tip segment 26, not shown in FIG. 6, there may be leads for electrodes 616 and control elements for deflection of the tip 50.

Some or all of the catheter shaft 27 or tip 50 may also have additional features for deliverability and torque transmission, such as directional braiding or selective elastic polymeric jackets. The high torque shaft allows the plane of the deflected tip to rotate to facilitate precise positioning at a target site such as the ostium of a pulmonary vein. Torque transmission capability is also useful when the catheter tip has a balloon with circumferential electrodes, but its shape may otherwise limit translation in certain directions when deployed. . The stiffness and torque characteristics of shaft 27 add smooth pushability, while the flexible conformability of balloon 610 allows circular alignment of electrodes 616 to achieve proper contact with the venous ostium. Allows for atraumatic matching of balloon 610 to local tissue anatomy.

The outer surface of the balloon 610 can have a plurality of independently controlled electrodes 616 adhered to the surface of the balloon and circumferentially oriented to create a circular contact profile with the pulmonary vein ostia. The shape of the electrodes may be selected to allow for similar inter-electrode spacing axially across varying diameters of the inflated balloon between proximal end 612 and distal end 614. Each electrode may be gold plated for electrical conductivity and perforated with individual holes to allow fluid flow from the inside to the outside of the balloon. For example, heparinized saline may be delivered through Luer fitting 40 of handle 100 for irrigation flow.

Electrodes 616 can extend from a proximal end 612 to a distal end 614 of balloon 610 in a flexible circuit. Having independently tensioned electrodes in this manner allows each electrode to independently deliver energy and act as a thermocouple to sense temperature at each electrode interface. It is possible to have a conductor, such as a two-turn wire, routed through the wire. Energy may be delivered using RF, cryo, IRE, or other similar techniques.

A cross-sectional side view of the handle from FIG. 3 is illustrated in FIG. 7. Articulation knobs 210 may be axially secured to drive housing 410 such that they translate as a pair, such as using a collar, retaining ring, or set screw. In the example in FIG. 7, the thrust collar 314 is capable of transmitting push/pull forces between the knob and the drive housing. When thus fixed, when the knob is displaced distally or proximally along the longitudinal axis 111 relative to the outer housing 110, the same displacement is experienced by the drive housing. Alternatively, a portion of the articulation knob may extend proximally to be received within the drive housing, where it may be secured via a set screw or other means. Outer housing 110 may be configured to guide linear displacement of drive housing 410 while limiting or limiting the total range of movement available to the drive housing. This limitation to the displacement of drive housing 410 may also be experienced by articulation knob 210 as they may be coupled.

Linear deflection of the articulation knob 210 of the handle 100 may be translated into expansion or retraction of the expandable element via movement of the drive housing 410 within the outer housing 110. Alternatively, linear deflection of articulation knob 210 may be used to deflect the catheter tip in a direction related to the induced relative movement of drive housing 410. Actuation of the expandable element from the control handle provides procedural advantages and can eliminate the need for a separate expansion mechanism incorporated into the handle for this purpose. For example, as seen in FIG. 6, the proximal end 612 or distal end 614 of the balloon 610 is slidably disposed along the tip axis 51 and longitudinally coupled to the drive housing 410 within the handle 100. An extension collar 630 can be obtained. In this configuration, linear translation of the drive housing in a first direction can increase the radial size of the balloon, and translation of the drive housing in a second direction opposite the first direction can increase the radial size of the balloon. Radial size can be reduced.

Rotation of the articulation knob 210 of the handle 100 may be translated into angular deflection of the catheter shaft 27 or expansion of the expandable member at the catheter tip 50 via relative movement of the drive housing 410 within the outer housing 110. The piston carriage 510 in the drive housing 410 can have an external thread alignment that is received within a barrel nut 310 that has a corresponding internal thread alignment and is rotatably coupled to the articulation knob 210. The threads allow the knob 210 to linearly translate the piston carriage 510 in the drive housing 410 as the knob is rotated.

In one example, piston carriage 510 can have multiple parts that cooperate to engage or can be assembled to form a carriage. As shown in the cross-sectional views of the handle 100 in FIGS. 8 and 9, the carriage includes a right flexure rack 530 half and a left flexure rack 540 that are linearly translatable along the longitudinal axis 111 within the drive housing 410. Can have halves. Distally, the piston carriage can have a bolt with a right half 520 and a left half 521, at least one of which can have an external external thread 522.

In one example, the threads 522 of the right deflection rack 530 of the piston carriage 510 are engaged with the helical drive threads 316 of the barrel nut 310. When right flexural rack 530 and left flexural rack 540 are restricted from rotation within the drive housing, the drive threads of the barrel nut can act linearly with respect to the right flexural rack threads 522. As illustrated in FIG. 9, rotation of the articulation knob 210 and barrel nut 310 about the longitudinal axis 111 is achieved by driving the left flexural rack within the drive housing 410 by driving the external threads 522 of the right flexural rack. A corresponding linear translation of right flexural rack 530 relative to 540 may be caused.

This rotation of articulation knob 210 and the resulting relative translation between right half 530 and left half 540 of piston carriage 510 provides a mechanism for actuation of the aforementioned control member (not shown). can be. Actuation of the control member can occur, for example, by tensioning a wire or compressing a toggle element.

A control member can extend through catheter shaft 27 and cause deflection of distal catheter tip 50. For example, proximal translation of the right deflection rack 530 relative to the left deflection rack 540 tensions a control wire or cable coupled to the distal end of the catheter, causing the steerable tip to move into position (relative to a starting or neutral position). It can be angularly deflected in one direction. Similarly, distal translation of the right flexural rack 530 relative to the left flexural rack 540 tensions the second control wire or cable, causing the steerable tip to angularly move in a second direction opposite the first direction. It can be bent.

FIG. 10 shows the lower half 430 of the drive housing 410 with the piston carriage 510 disposed therein. Depending on the configuration, there are multiple ways to configure the relative movement of the right and left flexural racks 530 and 540 of the piston carriage 510 to provide separate and distinct tensions on the aforementioned control members (not shown). exist. In one configuration, control wires may be coupled directly to opposing halves of piston carriage 510. In an alternative configuration, one of the wires may be directly coupled to the piston carriage and the other wire may be coupled indirectly to the piston carriage through a direction reversing element such as a pin or pulley (not shown). Ru. In this way, both wires are kept taut, and relative movement of right flexural rack 530 in one direction with respect to left flexural rack 540 applies tension to one of the control wires and tension in the opposite direction. Relative motion applies tension to the other control wire. Equal and opposite translational motion between right flexural rack 530 and left flexural rack 540 may be maintained through the use of pinion gear 412 coupled to flexural rack teeth 541, as shown in the cross-sectional view of FIG. .

The coupling between the control member and the half of the piston carriage 510 allows for relative movement to actuate the control member. In this sense, "directly coupled" means that the control wire forms an operative pair with one of the flexural racks, but does not necessarily need to be attached to or integrated with one of the flexural racks. "Indirect coupling" means that the wire forms an operative pair (but is not necessarily attached as well) with one of the flexible racks only after passing through an intermediate element such as a pulley. I can do it. The wire may be maintained within the sheath along most of its length, or may be employed to ensure that it is not unduly angled or stressed when coupled to the piston carriage 510. It may be maintained with one or more strain relief methods.

Separate views of right flexural rack 530 and left flexural rack 540 are shown in FIGS. 12a and 12b, respectively. When mated together, the right drive bolt half 520 of the right deflection rack 530 and the left drive bolt half 521 of the left deflection rack 540 have a cylindrical internal cavity for the catheter sheath to extend therethrough. 512 can be formed. From the cross-sectional view of FIG. 11, the pinion 412 ensures that there is no relative slippage between the right flexural rack 530 and the left flexural rack 540 by simultaneously engaging the corresponding internal teeth 541 of both flexural racks. You can be sure. By measuring the relative translation of the right and left deflection racks, the pinion teeth provide a consistent and repeatable relative deflection for incremental rotations of the articulation knob 210. These deflections may be transmitted to the control member of the handle. A particular magnitude of angular rotation of articulation knob 210 may correspond to a particular magnitude of linear translation of right deflection rack 530, and thus a particular magnitude of angular deflection of catheter steerable tip 50. Can be triggered. The pinion rotation is smooth and reliable with tip deflection so that experienced physicians can comfortably move and manipulate the catheter with the control handle without the need for a visual reference check of handle orientation. Ensure that it occurs in style.

An exemplary profile of the lower half 430 of the drive housing 410 is illustrated in FIG. 13. At least a portion of the drive housing lower half 430 has a track formed therein for guiding the deflection of the right flexure rack 530 and the left flexure rack 540 of the piston carriage 510 and serving as an anti-rotation feature for them. 436 can have longitudinal grooves or rails 436. The rail 436 can respond to rotational torque generated from rotation of the articulation knob 210 such that the movement of the flexible rack is linear along the longitudinal axis 111 of the handle. The lower drive housing half 430 can also have a pinion hub 432 to provide spindle positioning for the pinion 412. Additionally, distally facing features molded into the lower drive housing half 430 can form a termination or physical stop 438 for proximal translation of the flexible racks 530, 540. Alternatively, length-adjustable physical stops may be installed to define the extreme range of movement of the flexible rack. The length can be adjustable by screws or through the use of shims. Any method may be used to engage the physical stop with the rail 436 of the drive housing 410, such as adhesive or press fit.

The linear displacement of drive housing 410 itself may be controlled through the axial placement of circumferential grooves or thrust slots 434. The thrust slot may be sized to receive the collar 314 of the barrel nut 310 to provide transmission of push/pull forces applied by the user to the knob 210 to the drive housing. Since the barrel nut 310 is of a fixed length, the longitudinal placement of the thrust slot can 434 can define the range of linear movement provided to the articulation knob. For example, a more proximally located thrust slot 434 would place the barrel nut 310 closer to the proximal end 112 of the handle 100. This position allows for a greater length of travel for drive housing 410 within outer housing 110.

Representative views of the articulation knob of the present design and its various features are shown in Figures 14a-c. The knob may be cylindrical or similarly shaped, with raised, overmolded, or other contours on the outer surface to give a more secure grip with the thumb, or thumb and index finger, of the hand on which the user operates. can have characteristics. Knob 210 can be tapered at distal end 113 for passage of catheter shaft 27. The distal end 113 can be chamfered with a gentle edge radius to allow free translation and rotation of the knob while not having sharp corners that could twist or damage the shaft.

14b and 14c, the interior of the articulation knob 210 can have a knob hub 212 for interfacing with a barrel nut 310 or other component features of the handle 100. Rotation may be transmitted from the knob to the barrel nut through one or more keyways 214 formed within the hub. These keyways can be tapered or square, and the length can vary based on the size of the hub and the torsional load to be transferred. Alternatively, knob hub 212 may be shrink fit onto barrel nut 310.

15 and 16 show a perspective view and a cross-sectional view, respectively, of a barrel nut 310. The barrel nut can have a substantially tubular profile and have a diameter that is reduced distally for insertion into the interior of articulation knob 210. In one embodiment, the barrel nut 310 has one or more outer shells that cooperatively engage or fit into a corresponding keyway 214 (see FIG. 14c) of the articulation knob. It has a key 312 extending in the direction. Key 312 can function as a retention mechanism to prevent relative angular movement and transmit torque between knob 210 and barrel nut 310. This couples the barrel nut 310 for rotation with the articulation knob 210. Accordingly, the rotational and translational movements of the knob 210 are transmitted to the barrel nut 310, which may operate as a single unit relative to the outer housing 110 of the handle 100.

A thrust collar 314 axially proximate the proximal end 318 of the barrel nut 310 transmits push/pull forces between the knob and the drive housing 410 by mating with a circumferential slot 434 in the drive housing. can do. Slot 434 and thrust collar 314 can lock longitudinal translation of the articulation knob and drive housing while allowing free rotational movement of the knob.

Female drive spline threads 316 may be machined or formed into the inner surface of the barrel nut, as illustrated in the cross-sectional view of FIG. When torque is transferred from the articulation knob 210 to the barrel nut 310, the spline threads 316 can engage the drive bolt threads 522 of either the right flexure rack 530 or the left flexure rack 540 of the piston carriage 510 (see FIG. 10). Rotation of the spline thus drives relative linear displacement between right flexural rack 530 and left flexural rack 540.

Features that may be formed or machined into the surface of the knob hub 212 or the surface of the barrel nut 310 to function as set points can be configured to provide specific angular rotations such that various clocking positions are engaged as the articulating knob 210. The tip is rotated to maintain a specific tip deflection corresponding to the amount. These features, such as detents or axial relief notches or grooves, selectively maintain a particular tip deflection, giving the knob the ability to "click in" and alert the user when a particular discrete engagement point is reached. Can provide tactile feedback.

Alternatively, friction devices such as rubber grommets or O-rings can be used to connect the barrel nut 310 and drive housing to create a friction lock that increases rotational resistance and maintains the articulation knob 210 in the desired rotational position relative to the axis. 410.

Many expandable elements utilized with steerable catheters operate the expandable element between a collapsed delivery state within the delivery catheter or sheath and an expanded and deployed state at the target site. requires a separate activation mechanism in addition to manipulating the control handle. For example, the expandable ablation balloon 610 shown in FIG. 6 may be expanded to a deployed configuration to provide atraumatic engagement with the ostium of a pulmonary vein. It is an advantage of the present design to combine expansion and retraction of the balloon with the steerable functionality of the control handle to control the radial size of the balloon without any additional auxiliary mechanisms.

To deliver the steerable catheter tip 50 with the expandable element or balloon 610 within the guide sheath or outer catheter to the target location, the balloon 610 and any associated leads and electrodes are first collapsed to a smaller diameter. may be required. The folded diameter can conform to a typical guide sheath of a certain inner diameter, such as 13.8F. The displacement feature of the articulation knob 210 of the handle 100 can be lengthened from its nominal generally spherical shape (FIG. 17b) to an elongated football-like profile (FIG. 17a) with a smaller radial size for delivery. The advancement mechanism 620 can be articulated. This movement can be similar to a tubular bellows or expansion joint whose diameter changes with respect to the axial position of the corresponding end. In some cases, advancement mechanism 620 may be adhered to the distal end of balloon 614 using adhesive or other suitable means. Alternatively, the distal end 614 of the balloon can be glued to a rigid extension collar 630 to provide a sturdy attachment point.

Advancement mechanism 620 can extend proximally over the length of catheter shaft 27 so as to be coupled to drive housing 410 in control handle 100 . In this manner, advancement mechanism 620 telescopes ( telescopically). The advancement mechanism can be a tube with an internal lumen 622 for guidewires and other small ancillary devices, and a conduit to direct irrigation for cooling and prevention of blood clotting.

The advancement mechanism 620 can have sufficient columnar stiffness to smoothly transfer thrust loads to translate the distal end of the expandable member, while providing sufficient column stiffness for delivery through the tortuous vessel to the target site. It also has sufficient lateral flexibility. In one example, the advancement mechanism may be constructed from a sturdy, chemically resistant polymeric material, such as flexible polyimide tubing. Alternatively, the advancement mechanism can be a tubular, coiled or looped support structure covered with an outer jacket.

In one embodiment, the control elements for distal tip deflection include a pair of controls extending substantially along the length of catheter shaft 27, as shown in FIG. 18 and the corresponding close-up representation of FIG. It can be wire 29. As previously discussed, wire 29 may be coupled proximally to right flexural rack 530 and left flexural rack 540 of piston carriage 510 within drive housing 410 . The control wire may be constructed of steel or high molecular weight polymer with sufficient tensile strength to cause tip deflection when the articulation knob 210 is rotated about the handle axis 111.

Wires 29 may be coupled or crimped distally on either side of cross or T-shaped member 28. Clockwise rotation of the articulation knob can tension the wires joined to one side of the T-shaped member, causing the catheter sheath or shaft 27 to deflect in a first direction relative to the nominal starting position. cause. Similarly, counterclockwise rotation of the knob can tension a second wire secured to the opposite side of the T-shaped member, causing the shaft to deflect in a second direction. A direction reversing element, such as a pin or pulley, may be used in the handle so that both wires 29 are kept in tension regardless of which direction the knob is rotated.

20a-20f are diagrammatic representations of the order of use for the control handle 100 of a steerable catheter with a distal expandable element as described herein. For purposes of illustration, the catheter is assumed to be configured with an expandable element, such as an ablation balloon 610 as shown in FIGS. 17a and 17b. The drawing features a cross-sectional central portion of outer housing 110 so that movement of components within the housing as a result of manipulation of articulation knob 210 can be seen.

FIG. 20a shows the articulation knob 210, drive housing 410, and piston carriage 510 of the control handle 100 at the most proximal limit of longitudinal movement. The right flexural rack 530 and the left flexural rack 540 of the piston carriage 510 are axially aligned and the drive bolt threads 522 of the right drive bolt half 520 are engaged with the internal threads of the barrel nut 310 . The piston carriage can move along one or more expansion pistons 542 within the housing. Arrows superimposed on the articulation knob indicate the directions of rotation and translation available for articulating the knob.

Distal linear translation of articulation knob 210 from the nominal starting position of FIG. 20a is shown in FIG. 20b. Thrust collar 314 of barrel nut 310 drives drive housing 410 such that right flexure rack 530 and left flexure rack 540 of piston carriage 510 also translate distally along one or more expansion pistons 542. Can be pulled distally. Distal translation of knob 210 can push advancement mechanism 620 and extension collar 630 downstream to reduce the radial size of balloon 610 (see FIG. 17a). Full distal extension of the knob allows the balloon to be fully collapsed for repositioning during a procedure or for resheathing for withdrawal from the patient.

Referring to FIG. 20c, the applied distal translation of articulation knob 210 may be maintained while independently rotating the knob about longitudinal axis 111. Rotation of knob 210 can also rotate barrel nut 310. The helical female thread 316 of the barrel nut 310 can engage and drive the male thread 522 of the right half of the drive bolt 520, dividing the right flexural rack 530 and the left flexural rack 540 and axially Translate. Right deflection rack 530 may be displaced proximally along expansion piston 542, as shown in FIG. 20d. Engagement of the pinion 412 with teeth 541 of both right and left flexure racks 530 and 540 may also cause a corresponding distal translation of the left flexure rack. Control members or wires (not shown) connected to one or both of the right and left deflection racks can be tensioned by these translations to deflect the catheter shaft 27.

FIG. 20e is demonstrated by continued axial misalignment of right and left deflection racks 530 and 540 while the user is translating articulation knob 210 proximally along longitudinal axis 111. 2 illustrates that the deflection exhibited by catheter shaft 27 can be maintained as shown in FIG. In the reverse of Figure 20b, proximal movement of the knob can pull the advancement mechanism 620 and extension collar 630 proximally to begin or resume the ablation procedure, increasing the radial size of the balloon (Figure 17b reference).

When the articulation knob 210 is manipulated back to its original longitudinal starting position, the knob may be rotated in the opposite direction of the rotation applied in FIG. 20c. Rotation of the barrel nut can drive the threads 522 of the right flexural rack 530 to distally translate the right flexural rack 530 and the left flexural rack 540 of the piston carriage 510, as shown in FIG. 20f. Pinion 412 is rotated to return to longitudinal alignment. Rotation of the knob can also return catheter shaft 27 to its initial undeflected state.

Alternatively, the linear translation of articulation knob 210 and the induced movement of right retraction rack 530 and left retraction rack 540 may be coupled to deflection of the catheter tip. In this case, rotation of articulation knob 210 may be used to change the radial size of the expandable element or balloon, or to activate and manipulate various diagnostic capabilities of the catheter.

The multi-electrode balloon 610 of FIG. 6 is shown in FIG. 21 performing an ablation treatment of the pulmonary vein 70 in the left atrium. The length of the electrode 616 of the ablation balloon 610 may be selected to ensure contact with the target tissue wall 72 even if the catheter is not perfectly aligned with the ostium of the pulmonary vein 70. Multiple electrodes 616 may be arranged independently of each other. Functionally, this allows the amount of power delivered to each electrode to be controlled separately to improve the safety and quality of the lesions formed in the ablation zone 56. Leads from an energy source (not shown) may be shorted to the pads of electrode 616, where the change in voltage is applied as the electrode is heated via conductive heat transfer from the ablated tissue. can be correlated to changes in temperature.

When deployed from the sheath or outer catheter 10, the balloon 610 may be expanded from its collapsed state to isolate the vein. Similar to the previously described process, the balloon translates the articulation knob 210 proximally to pull the advancement mechanism 620 and extension collar 630 at the balloon's distal end 614 toward its proximal end 612. It can be expanded by increasing the diameter.

Ablation catheters with multifunctional tips are often fitted with a small pump for irrigation. For example, heparinized normal saline from a pump is delivered through the Luer fitting 40 in the handle 100 to the electrode, often with holes drilled to allow fluid flow from the inside of the balloon 610 to the outside. It can be delivered distally to pad 616. Irrigation flow 58 may enable tip functions such as balloon inflation and cooling of the ablation electrode 616 and the ablation tissue interface at the ablation zone 56. Flow 58 also functions to move blood away from the treatment site to maintain uninterrupted access.

Lumen 622 of advancement mechanism 620 may also be used to deploy distal irrigation, contrast media, or auxiliary devices. Such devices can include a guidewire or small diameter diagnostic catheter 60, as seen in FIG. The diagnostic catheter can be of hypotube construction and can be deployed in a hoop shape distally from lumen 622 for stimulation and recording of signals within the atria of the heart.

22 and 23 are each a flow diagram including method steps for performing a medical procedure using the control handles disclosed herein. The method steps may be implemented by any of the devices and/or apparatuses described herein and may be performed in an order other than listed.

Referring to method 2200 outlined in FIG. 22, step 2210 involves introducing a catheter for an intracardiac procedure. The catheter can include a catheter shaft having a proximal region and a deflectable distal region, an expandable element or member proximate the distal end of the shaft, and a control handle. The control handle can have an outer shell, a drive assembly, and a distal knob assembly having an internal drive spline and capable of linear translation along and rotation about a longitudinal axis of the handle. Step 2220 involves movably positioning the drive assembly within the outer shell of the control handle such that the drive assembly can translate along the longitudinal axis of the handle. The drive assembly can have an inner housing, a distal drive bolt with external threads, and a split piston carriage.

At step 2230, the split piston carriage is engaged with the helical threads of the internal drive spline of the knob assembly such that at least a portion of the split piston carriage is movable relative to the drive housing. When engaged, rotation of the knob assembly results in linear translation of at least a portion of the piston carriage within the drive housing. At step 2240, the control handle is configured for one-handed operation, allowing the thumb and index finger to operate all possible functions of the handle without the need for visual reference.

Manipulation of the distal knob assembly of the control handle can actuate various functions of the steerable tip of the catheter. Step 2250 can involve configuring the distal knob assembly to longitudinally translate the drive assembly relative to the outer shell. This translation can actuate a change in the radial size of the expandable element at the distal end of the steerable catheter. Distal translation of the drive assembly can decrease the radial size, while proximal movement of the drive assembly can increase the radial size.

Referring to step 2260 of FIG. 22 and step 2310 of FIG. 23, rotation of the distal knob assembly can angularly deflect the distal region of the catheter. In one embodiment, the deflection is such that clockwise rotation of the knob causes deflection of the distal region in a first direction and counterclockwise rotation causes deflection in a second direction opposite the first direction. , can be planar.

Further in FIG. 23, in step 2320, linear translation of the drive assembly and distal knob assembly may be coupled independently of rotation of the knob assembly. A specific linear translation of the drive assembly and knob assembly may then be maintained while rotating the knob to deflect and steer the distal region of the catheter. At step 2330, the control handle distal knob assembly may have limited overall translational and rotational movement. For example, the physical stop feature may be molded into the outer shell of the handle or may be a shim provided to limit the total proximal and distal movement available to the drive housing. The length of the externally threaded portion of the deflection rack can be selected to stop further knob rotation in a clockwise or counterclockwise direction, setting design limits for catheter tip deflection. The groove or relief is configured to engage the knob assembly at varying distances of translation such that the intermediate radial size of the expandable element can be influenced. Intermediate sizes can be advantageous by allowing the expandable element to be matched in size to fit various features or geometries of the target vasculature. Those skilled in the art will appreciate other benefits of being able to set travel limits or adjust the size of the expandable element of the catheter tip in-situ.

Step 2340 involves linearly translating the distal knob assembly to increase the radial size of the expandable element. This process can be useful for performing diagnosis, therapy, and/or other treatments. For example, and without limitation, a cardiac ablation procedure may involve contacting tissue surrounding the entrance of a pulmonary vein with one or more electrodes of a catheter tip for delivery of energy. Energy from the one or more electrodes can then be used to ablate tissue and form a lesion of scar tissue in the treatment of PAF or other cardiac arrhythmias, step 2350. In other examples, the energy may be used for imaging or mapping procedures.

Once the procedure is complete, it is often necessary to retract the deployed device into a sheath or outer catheter so that it can be safely removed from the patient. At step 2360, the distal knob assembly is linearly translated to reduce the radial size of the expandable element so that it can be retracted into the inner diameter of the sheath or outer catheter.

The invention is not necessarily limited to the examples described, but may vary in arrangement and detail. The terms "distal" and "proximal" are used throughout the foregoing description and are intended to refer to position and orientation relative to the treating physician. Thus, "distal" or "distally" refers to a location or direction away from the physician. Similarly, "proximal" or "proximally" refers to a location near or toward a physician. Further, unless the context clearly dictates otherwise, the singular forms "a," "an," and "the" include plural referents.

As used herein, the term "about" or "approximately" for any numerical value or range of numbers refers to It indicates the appropriate dimensional tolerances to function along. More specifically, "about" or "approximately" may refer to a range of values of ±20% of the recited value; for example, "about 90%" may refer to a range of values between 71% and 99% of the value. It may also refer to a range.

When describing example embodiments, terminology is utilized for the sake of clarity. Each term is intended to have its broadest meaning as understood by those skilled in the art, and all techniques that act in a similar manner to accomplish a similar purpose without departing from the scope and spirit of the invention. is intended to include equivalents. It is also to be understood that reference to one or more steps of a method does not exclude the presence of additional method steps or intervening method steps between those explicitly identified steps. Some steps of the method may be performed in a different order than described herein without departing from the scope of the disclosed technology. Similarly, references to one or more components in a device or system do not exclude the presence of additional components or intervening components between those explicitly identified components. I also want to be understood. In the interest of clarity and brevity, not all possible combinations are listed, and such modifications are often obvious to those skilled in the art and are within the scope of the following claims. Something is intended.

[Mode of implementation]
(1) A control handle for a catheter having a steerable tip, the control handle comprising:
a tubular outer housing defining a longitudinal axis, a proximal end, and a distal end;
an articulation knob adjacent the distal end of the tubular outer housing, the knob being rotatable about the longitudinal axis of the tubular outer housing and linearly displaceable along the longitudinal axis; There is an articulation knob,
a drive housing movably disposed within the tubular outer housing and coupled to the articulation knob, the drive housing comprising a split piston carriage and a pinion, the articulation knob comprising:
imparting a first linear displacement to the drive housing when the articulation knob is rotated clockwise about the longitudinal axis of the tubular outer housing;
when the articulation knob is rotated counterclockwise about the longitudinal axis of the tubular outer housing, it imparts a second linear displacement to the drive housing opposite to the first linear displacement; and The motion knob is configured to change the radial size of the expandable element on the distal end of the steerable catheter when the motion knob is linearly displaced a distance parallel to the longitudinal axis. a control handle configured to apply a third linear displacement to the drive housing;
(2) The control handle of embodiment 1, further comprising an advancement mechanism mechanically coupled distally to the expandable element and proximally to the drive housing.
3. The control handle of embodiment 2, wherein linear translation in the advancement mechanism causes a change in radial size of the expandable element.
(4) the first linear displacement of the drive housing is configured to actuate a first control member of the steerable tip, and the second linear displacement of the drive housing is configured to actuate a first control member of the steerable tip; A control handle according to embodiment 1, configured to actuate a second control member on the tip.
(5) The control handle of embodiment 4, wherein each of the first control member and the second control member comprises a control wire.

6. The control handle of embodiment 1, wherein the expandable element comprises a balloon.
7. The control handle of claim 6, wherein the balloon comprises a plurality of independently controlled electrodes equally spaced around a circumference of the balloon.
8. The control handle of claim 2, wherein the advancement mechanism comprises an elongate tubular member having an internal hollow lumen.
9. The control handle of embodiment 1, wherein the articulation knob further comprises a hub, a proximal end, a distal opening, and at least one keyway.
(10) further comprising a barrel nut coupled to the articulation knob and rotatable about the longitudinal axis of the tubular outer housing, the barrel nut having one or more keys disposed at one end; 10. The control handle of embodiment 9, comprising: a thrust collar at the other end; and a drive spline located inside the barrel nut.

(11) the barrel nut is longitudinally coupled to the drive housing by the thrust collar, the thrust collar locking the drive housing when the articulation knob is linearly displaced about the longitudinal axis; 11. The control handle of embodiment 10, wherein the control handle is configured for linear displacement.
12. The control handle of embodiment 10, wherein the barrel nut is configured to be rotationally coupled to the articulation knob by the one or more keys.
(13) the drive spline is configured to engage threads of the split piston carriage to displace at least a portion of the piston carriage along a linear path when the articulation knob is rotated; 11. The control handle of embodiment 10, wherein the control handle is
14. The control handle of claim 1, wherein the split piston carriage of the drive housing includes a drive bolt, a right deflection rack, and a left deflection rack.
15. The control handle of embodiment 14, wherein clockwise rotation of the articulation knob results in linear translation of the right deflection rack relative to the left deflection rack in a first direction.

16. The articulation knob of embodiment 15, wherein counterclockwise rotation of the articulation knob results in a linear translation of the right flexural rack relative to the left flexural rack in a second direction opposite the first direction. control handle.
Embodiment 15: The present invention further comprises a pinion coupled to the right flexural rack and the left flexural rack, the pinion rotating as the right flexural rack linearly translates with respect to the left flexural rack. Control handles as described in .
18. The control handle of claim 1, wherein the articulation knob is linearly displaceable independently of being rotated about the longitudinal axis.
19. The control handle of claim 8, wherein the elongated tubular member of the advancement mechanism comprises flexible polyimide tubing.
(20) The control handle of embodiment 1, further comprising a Luer fitting configured to receive fluid injection.

Claims (20)

A control handle for a catheter having a steerable tip, the control handle comprising:
a tubular outer housing defining a longitudinal axis, a proximal end, and a distal end;
an articulation knob adjacent the distal end of the tubular outer housing, the knob being rotatable about the longitudinal axis of the tubular outer housing and linearly displaceable along the longitudinal axis; There is an articulation knob,
a drive housing movably disposed within the tubular outer housing and coupled to the articulation knob, the drive housing comprising a split piston carriage and a pinion, the articulation knob comprising:
imparting a first linear displacement to the drive housing when the articulation knob is rotated clockwise about the longitudinal axis of the tubular outer housing;
when the articulation knob is rotated counterclockwise about the longitudinal axis of the tubular outer housing, it imparts a second linear displacement to the drive housing opposite to the first linear displacement; and The motion knob is configured to change the radial size of the expandable element on the distal end of the steerable catheter when the motion knob is linearly displaced a distance parallel to the longitudinal axis. a control handle configured to apply a third linear displacement to the drive housing; The control handle of claim 1, further comprising an advancement mechanism mechanically coupled distally to the expandable element and proximally to the drive housing. 3. The control handle of claim 2, wherein linear translation in the advancement mechanism causes a change in radial size of the expandable element. The first linear displacement of the drive housing is configured to actuate a first control member of the steerable tip, and the second linear displacement of the drive housing is configured to actuate a first control member of the steerable tip. 2. The control handle of claim 1, wherein the control handle is configured to actuate two control members. 5. The control handle of claim 4, wherein each of the first control member and the second control member comprises a control wire. The control handle of claim 1, wherein the expandable element comprises a balloon. 7. The control handle of claim 6, wherein the balloon comprises a plurality of independently controlled electrodes equally spaced around the circumference of the balloon. The control handle of claim 2, wherein the advancement mechanism comprises an elongate tubular member having an internal hollow lumen. The control handle of claim 1, wherein the articulation knob further comprises a hub, a proximal end, a distal opening, and at least one keyway. further comprising a barrel nut coupled to the articulation knob and rotatable about the longitudinal axis of the tubular outer housing, the barrel nut having one or more keys disposed at one end; 10. The control handle of claim 9, comprising a thrust collar at an end and a drive spline located inside the barrel nut. The barrel nut is longitudinally coupled to the drive housing by the thrust collar, the thrust collar linearly displacing the drive housing when the articulation knob is linearly displaced about the longitudinal axis. 11. The control handle of claim 10, wherein the control handle is configured to displace. 11. The control handle of claim 10, wherein the barrel nut is configured to be rotationally coupled to the articulation knob by the one or more keys. The drive spline is configured to engage threads of the split piston carriage to displace at least a portion of the piston carriage along a linear path when the articulation knob is rotated. 11. The control handle of claim 10. The control handle of claim 1, wherein the split piston carriage of the drive housing includes a drive bolt, a right deflection rack, and a left deflection rack. 15. The control handle of claim 14, wherein clockwise rotation of the articulation knob results in a linear translation of the right flexural rack relative to the left flexural rack in a first direction. 16. The control handle of claim 15, wherein counterclockwise rotation of the articulation knob results in a linear translation of the right flexural rack relative to the left flexural rack in a second direction opposite the first direction. 16. The rack of claim 15, further comprising a pinion coupled to the right flexural rack and the left flexural rack, the pinion rotating as the right flexural rack linearly translates with respect to the left flexural rack. control handle. The control handle of claim 1, wherein the articulation knob is linearly displaceable independently of being rotated about the longitudinal axis. 9. The control handle of claim 8, wherein the elongate tubular member of the advancement mechanism comprises flexible polyimide tubing. The control handle of claim 1, further comprising a Luer fitting configured to receive fluid injection.

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